Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:59 AM
Ignite Modification Date:
2025-12-24 @ 11:59 AM
NCT ID:
NCT01806961
Brief Summary:
Determine the recurrence rate of actinic keratosis (AK) lesions in patients with complete clinical clearance at the end of the previous trial SP848-AK-1101 at 6 and 12 months of follow-up.
Detailed Description:
Efficacy Evaluation:
• Primarily based on clinical inspection of the former 25 cm2 treatment area and count of the AK-lesions.
Safety Evaluation:
* Evaluation of adverse events (AEs) and serious adverse events (SAEs)
* Evaluation of newly occurred dermal adverse events (AEs) and serious adverse events (SAEs) in the previous treatment area at 6 months and 12 months of follow-up (local tolerability).
* Follow-up of unresolved adverse and serious adverse events that occurred in the previous trial SP848-AK-1101.
* Follow-up of unresolved abnormal laboratory values that occurred in the previous trial SP848-AK-1101.
Study:
NCT01806961
Study Brief:
Protocol Section:
NCT01806961